Bioequivalence and Bioavailability Forum • Replicate Design

Replicate Design [Two-Stage / GS Designs]

posted by Naveen Kumar – India, 2014-06-23 15:19 (4018 d 10:22 ago) – Posting: # 13124
Views: 6,576

Dear All,

Please suggest, can we design full replicate bioequivalence study (molecule is highly variable) in stages for EMEA submission.

My concern is Power will play pivotal role in stage design, which not be in replicate (full) designs.

Regards,
Naveen Kumar.SR

Edit: Category and subject line changed. [Helmut]

Complete thread:

Replicate DesignNaveen Kumar 2014-06-23 13:19
- Replicate Design ElMaestro 2014-06-23 13:32
  - Science fiction Helmut 2014-06-23 14:53
    - Science fiction Naveen Kumar 2014-06-28 07:26
      - Interim analysis? Helmut 2014-06-28 12:09